Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0237101842
Study information
Scientific title
Acronym
Study hypothesis
The aim of the present open-labelled, randomised controlled study is to examine effectiveness of insulin glargine in combination with metformin 1 g twice daily (bid) - 1 g three times a day (tds) compared with insulatard combined with metformin (same dose) in type two diabetic patients currently treated with insulatard/metformin combination therapy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetes
Intervention
Randomised controlled trial. Patients randomised to:
1. Nocturnal insulin glargine
2. Human insulatard in combination with metformin
Intervention type
Drug
Phase
Not Specified
Drug names
Glargine, metformin, insulatard
Primary outcome measures
1. Glycosylated haemoglobin (HbA1c)
2. Tasting blood glucose
3. Frequency of hypoglycaemia
4. Weight change
Secondary outcome measures
Well being and diabetes treatment satisfaction measured using appropriate validated questionnaires.
Overall trial start date
01/08/2001
Overall trial end date
31/07/2003
Reason abandoned
Eligibility
Participant inclusion criteria
80 patients.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2001
Recruitment end date
31/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Research Fellow
Prescot, Merseyside
L35 5DR
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St Helens and Knowsley Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary